Using EEG to Predict Depression Treatment Response to rTMS in Patients With Major Depression

Using EEG to Predict Depression Treatment Response to Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Major Depression

Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing rTMS treatment of depression.

Study Overview

• Status: Withdrawn
• Conditions: Major Depression; Repetitive Transcranial Magnetic Stimulation
• Intervention / Treatment: Diagnostic test: Electroencephalogram (EEG)

Detailed Description

The study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using Repetitive Transcranial Magnetic Stimulation (according to FDA approved rTMS standard care practices) also will undergo EEG recording before Repetitive Transcranial Magnetic Stimulation treatment begins, and at the completion of treatment. The Hamilton Depression Rating Scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment.

The neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for Repetitive Transcranial Magnetic Stimulation. Therefore, it is expected to recruit 24 subjects into the research study over a two-year period.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Starlie C Belnap

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who will be treated for major depression using rTMS (according to standard care)

Description

Inclusion Criteria:

• Diagnosed with cancer
• Comorbid diagnosis of major depressive disorder
• Age ≥ 18 years
• Baseline Hamilton Depression Rating Scale (HDRS) score ≥ 18
• Failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or SSRIs, selective norepinephrine reuptake inhibitors or SNRIs, tricyclic antidepressants or TCAs). A failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects.

Exclusion Criteria:

• History of seizure or epilepsy
• History of concussion
• History of bipolar disorder
• Comorbid psychotic disorder
• Primary brain tumor or metastasis to brain
• Active comorbid substance use disorder
• History or current diagnosis of dementia
• Current pregnancy
• Unable to attend regular treatment sessions
• Any other condition in which a physician investigator feels may subject the participant to undue risk

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electroencephalogram (EEG); All participants will undergo EEG recording at baseline and end of treatment for a duration of 10-20 minutes per session.	Diagnostic test: Electroencephalogram (EEG); EEG measures brain activity by recording the spontaneous brain electrical activity and evoked responses non-invasively from the scalp. Reusable Tangle Free 10mm EEG Cup Electrodes will be placed on the subject's scalp using the 10-20 system montage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hamilton Depression Rating Scale score	Hamilton Depression Rating Scale is used to measure severity of depression on a scale from 0 (no depression) to 52 (most severe depression).	baseline, and weekly until study completion, which can be up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalograph (EEG) scalp signal changes over time	Change in brain activity as measured by the EEG in microvolts.Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA).	baseline, end of treatment, which can be up to 6 weeks

Collaborators and Investigators

• Sponsor: Baptist Health South Florida
• Collaborators: Florida International University
• Investigators: Principal Investigator: Geetha Nampiaparampil, MD, Miami Cancer Institute (MCI) at Baptist Health, Inc.

Publications and helpful links

Helpful Links

• Miami Neuroscience Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2030
• Study Completion (ANTICIPATED): December 1, 2031

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: rTMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: TMS Depression

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No